Computerized System Validation - NUSAGE - National University of ...

National University of Singapore Academy of GxP Excellence (NUSAGE)
and PharmEng Technology Presents
Computerized System Validation
Part of the Pharmaceutical and Biotechnology Training Courses
Instructor
Steven Beaton, B.Sc.
* Instructor may be subject to
change due to unforeseeable
circumstances. In case of a
change, updated instructor
profile will be made available to
the organizer and the
attendees.
Date and Time
13-14 September 2012
9 AM – 5 PM
Location
Global Classroom
Department of Pharmacy
National University of Singapore
S4 Level 5
18 Science Drive 4
Singapore 117543
Tel: 65162647 / 8
Fax: 67791554
Website: www.NUSAGE.nus.edu.sg
Location:
Please view NUS interactive campus map at http://www.nus.edu.sg/campusmap/,
look under Science, Department of Pharmacy.
By taxi/foot:
Please turn into and drive/walk along Science Drive 4, then go under building with
"Fire ENGINE ACCESS" sign. Go straight down to loading bay where S4 building will be
right in front.
By car:
Please park at the Visitors' lots inside University Hall (Tan Chin Tuan Wing), Carpark
6B along Lower Kent Ridge Road just next to Science Drive 4.Then walk through level
2 of Lee Kong Chian Wing towards Science Drive 4, and walk along to reach S4 as per
above.
To Library: Please proceed to S4 Level 2
To Pharmacy Global Classroom: Please proceed to S4 Level 5
N U S A G E - P h a r m E n g 2 0 1 2 P r o f e s s i o n a l T r a i n i n g P r o g r a m

N U S A G E - P h a r m E n g 2 0 1 2 P r o f e s s i o n a l T r a i n i n g P r o g r a m
C o m p u t e r i z e d S y s t e m Va l i d a t i o n
Objective
The course is designed to provide a thorough understanding of computer system validation. In addition,
the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits
into the validation process. The attendee will become familiar with expected content for computer
validation deliverables through examination of how to develop the validation rationale for a variety of
circumstances.
Description
The course will examine the current GAMP version applied to validating PLC, software and control
systems. Both FDA and EU regulatory guidelines will be discussed. Also a discussion will be made on the
current 21 CFR part 11 regulations which cover topics such as background & impact of the regulations in
industry, details of regulations and implementing a validation program. Furthermore, the course will
discuss the computer validation life cycle from design, through construction, installation and live start
up for a typical software project will be described with details on the contents of key documents such as
URS, FDS, VMP, IQ, OQ, PQ. Finally, the objectives for risk assessment and the various techniques and
how to effectively implement to ensure critical risks are identified and correct level of validation is
carried out will be discussed.
Course Outline
• Regulations and guidelines for computer system validation
• Electronic signatures and records
• Overview of Software Categories (GAMP)
• Introduction to Computer Validation Life Cycle – Emphasis will be given on the contents
of key documents/activities such as URS, FDS, VMP, IQ, OQ and PQ
• Introduction to System Life Cycle Process
o Planning
o Design and Construction
o Acceptance Testing for developed systems (2 parts) – Acceptance at the supplier
site, Factory Acceptance Test (FAT) and Acceptance at the customer site, Site
Acceptance Test (SAT)
o Implementation and acceptance
o Ongoing operation
o Back up and Restore
o Diaster Recovery
o Contingency Planning
o Business Continuity
o Preventative maintenance
o Corrective maintenance (problem reporting)
o Change control
o Archiving of the system when replaced
o Retirement phase
• Risk assessment of computerized systems
Instructor
Steven Beaton, BSc, is a consultant
with PharmEng Technology,
Canada’s leading full service
consulting firm providing
validation, engineering and
regulatory affairs services to the
pharmaceutical, medical devices
and biotechnology industries in
North America and internationally.
Steven holds a Bachelor of Science
from Cape Breton University Nova
Scotia and completed further
graduate level technical programs
in Biotechnology and
Pharmaceutical Technology before
joining PharmEng. In his current
role Steven leads projects for
multinational pharmaceutical and
medical device manufacturers
including CIBA Vision, Bayer Health
Care and Sanofi Pasteur, in the
United States, Canada and Asia
Pacific region. Steven is an expert in
validation and GMP, specializing in
Technology Transfer and 21 CFR
Part 11 compliant computerized
systems. He has successfully
worked on a variety of Computer
Systems Validation (CSV) projects in
manufacturing and research
laboratories validating both
standalone computerized lab
instruments and complex
networked systems. With his
knowledge of 21 CFR Part 11
compliant systems, Steven has
helped his clients implement
controls, including audit trails,
password protection/security,
electronic signatures, and standard
operating procedures for systems
involved in processing electronic
data ensuring compliance with FDA
requirements.
Who Should Attend & What Participants will benefit from the course
This course is particularly useful for personnel in the Pharmaceutical/Medical
Device/HealthCare/Engineering Sectors of industry who need to gain an understanding in the principles
of GXP in a regulated environment and how to apply these to develop fully compliant systems. The
participants will be able to build upon their existing knowledge of computerized system validation
concepts and practices to learn how these approaches, concepts and practices can be applied to future
projects.

N U S A G E - P h a r m E n g 2 0 1 2 P r o f e s s i o n a l T r a i n i n g P r o g r a m
Computerized System Validation
Registration Form
Please Print or Type Clearly
Full Name & Title* (Prof/Dr/Mr/Mdm/Ms)
Job Title
% Knowledge on Subject Matter
Company
Business Address
Business Tel
Mobile No.
E-mail Address
Special Diet* ( Non-spicy / Vegetarian / Vegetarian w/o egg / No beef / Halal )
* Circle where appropriate
Fees:
S$1070 per delegate before GST.
Early bird discount 14 calendars before the course /
group discount of 5 or more delegates: 10% off per
delegate
Course Fees includes course materials, tea breaks
and lunch.
Please return completed forms by mail/fax to:
National University of Singapore
Department of Pharmacy
S4, Level 2
18 Science Drive 4
Singapore 117543
Fax: 67791554
Attn: Chen Yee Ju, Manager
NUS, Department of Pharmacy
phacyj@nus.edu.sg, DID: 65165878
Payment:
Only cheques are accepted. Please make cheques
payable to:
“National University of Singapore”
Payments must be received at least one week prior to
event.
Cancellations must be made in writing. If cancellations
are received 2 weeks prior to course, a full refund,
minus a handling fee of $75 will be issued. No refunds
will be granted thereafter. Substitutions are acceptable
if the registrant is not able to attend.

A b o u t t h e T r a i n i n g P r o v i d e r
PharmEng Technology (“PharmEng”), a division of PE Pharma Inc., provides professional development and
certification training programs throughout North America and Asia. We deliver over 35 courses to the
pharmaceutical, biotechnology, nutraceutical and medical devices industries in the areas of:
Past participant comments:
• cGMPs
• Validation
• Engineering
• Project Management
• Medical Devices
• Quality Compliance
• Quality Assurance
• Regulatory Affairs
• Manufacturing
“Best instructor and best coverage of this
subject that I’ve experienced yet. Great
session – so glad I came.” IMRIS Inc.
“… good course, especially the case
studies.” Genesys Venture Inc.
“It was a nice change that the instructor
had personal experience that I could
relate to.” Medicure Inc.
Why PharmEng Professional Training?
Unique curriculum that covers key areas critical to the success of the industry, through courses that
integrate theory and practice.
Advisory committee that includes members from industry, academia and government, ensuring that
important regulatory and industry issues are addressed.
Custom courses that cover both general and basic “know-how” as well as current challenges, issues and
new developments in the industry.
Instructors that have been selected among industry leaders and subject experts who will provide
challenging course work and valuable hands-on experience.
PharmEng delivers courses to two distinct groups:
1. Corporate Training: Experienced industry professionals who require current best practices in order
to keep up-to-date with industry standards, Good Manufacturing Practices (GMP’s) and regulations.
2. Career Training: Next generation individuals seeking careers in the industry who need practical skills
and “know-how” for the pharmaceutical and biotechnology workforce.
For those individuals requiring one day professional development programs, courses are available
through any of the PharmEng offices located throughout North America and Asia with access to course
listings, course availability and registration through the PharmEng website www.pharmeng.com.
Certification Programs
For career training and certification, PharmEng offers programs through national and internationallyrecognized
universities delivering certificate programs such as:
The Biopharmaceutical Technology Certificate Program for the University of Waterloo and the National
Tsing Hua University College of Life Science in Taiwan
The Biotechnology and Pharmaceutical Technology Program for Cape Breton University
Instructors and Course Materials
All instructors are subject matter experts with direct industry experience. Instructors include guest
speakers from industry, government and academia. Course materials are developed by PharmEng inhouse
and are constantly updated to keep current with the regulatory environment. As the industry
changes, so do the issues and challenges. Our courses, with supporting materials, link together:
• Training
• Regulations
• Government
• Industry
• Academia
• International Standards
Conferences
PharmEng offers conferences throughout the year in collaboration with Health Canada, and various
professional associations in biotechnology, pharmaceutical, medical devices, nutraceutical and healthcare
industries.

A b o u t t h e T r a i n i n g P r o v i d e r
PHARMENG CORE TRAINING COURSES
Current Good Manufacturing Practices
• GMP – Get More Productivity
• GMP – Concepts and Implementation
• cGMP’s for Drugs and Active
Pharmaceutical Ingredients
Manufacturers
cGMP training is tailored to meet your
company’s specific needs in one or all of
the following areas:
• Engineering
• Production
• Packaging
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Clinical Research
• New Drug Submission/Application
• Natural Health Products
• Active Pharmaceutical Ingredients
• Medical Devices
• Blood and Blood Products
• Practical cGMP
Engineering
• Commissioning and Validation of
Pharmaceutical and Biotechnology
Facilities
• Design and Validation of Critical Utility
Systems
• Process Analytical Technology (PAT)
• Design and Commissioning and
Validation of
• Pharmaceutical and Biotechnology
Facilities
Quality and Compliance
PharmEng® also provides customized
Good Laboratory Practices (GLP) and
Good Clinical Practices (GCP) training to
clients in order to assist companies in
moving forward with their pre-clinical
and clinical trials.
• Master Plan – Roadmap to Compliance
• Good Laboratory Practices (GLP)
• Pharmaceutical Quality Assurance and
Control
• GMP Programs – Planning and
Implementation
• Audit Programs and Annual Review
• Recall and Compliant Systems
• Standard Operating Procedures
• Corrective and Preventative Actions
(CAPA)
• Risk-based Approach to Inspecting
Quality Systems
Validation
• Analytical Methods Validation
• Process Validation
• Cleaning Validation
• Computer Systems Validation
• Validation of Sterilization Processes
Project Management
• Project Management in a Regulatory
Environment
• Project Management for Clinical
Research Studies
Medical Devices
• Medical Device Regulatory
Requirements
• Quality System Requirements – ISO
13485
• Quality Systems for Medical Devices
Manufacturing
• Manufacturing Control in the
Pharmaceutical Related Industries
• Pharmaceutical and Biotech
Manufacturing Processes
• Active Pharmaceutical Manufacturing
• Solid and Semi-Solid Dosage
Manufacturing
• Aseptic Manufacturing
• Sterile and Septic Processes
Regulatory Affairs
• Good Clinical Practices (GCP)
• New Drug Application/Submission
• Chemistry, Manufacturing and Control
• Natural Health Products Registration
PharmEng Technology, a division of PE Pharma Inc., headquartered in Toronto, Canada, is a fullconsulting
company that serves the pharmaceutical and biotechnology industries internationally.
Consulting services include project management, engineering, cGMP, validation, calibration,
regulatory compliance and certified service training.